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NightWare Open Enrollment Study

NCT03828656 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-03-04

No results posted yet for this study

Summary

This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

Conditions

  • PostTraumatic Stress Disorder
  • Sleep Disorder
  • Stress Disorder
  • Sleep Initiation and Maintenance Disorders
  • Combat Disorders
  • Nightmares Associated With Chronic Post-Traumatic Stress Disorder
  • Nightmare
  • Nightmares, REM-Sleep Type

Interventions

DEVICE

NightWare Therapeutic System

A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.

Sponsors & Collaborators

  • RationalPsych

    collaborator UNKNOWN

  • Center for International Emergency Medical Services

    collaborator OTHER

  • NightWare

    lead INDUSTRY

Principal Investigators

  • Daniel R Karlin, MD MA · RationalPsych

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03828656 on ClinicalTrials.gov